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FDA in Medical News

Covidien receives FDA clearance for its Puritan Bennett 840 ventilator system

Covidien (NYSE: COV), a leading global healthcare products company and recognized innovator in mechanical ventilation and respiratory care devices, announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Leak Compensation software feature for the P...

Chesson Labs Liquid Bandage Product NUVADERM(TM) Receives FDA 510(k) Market Clearance

DURHAM, N.C., Aug. 5 /PRNewswire/ -- Chesson Labs today announced receiving 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for NUVADERM(TM), the Company's liquid bandage product. The 510(k) clearance allows Chesson Labs to market and sell the product for use by...

Amgen and Wyeth Statement on FDA Announcement About Tumor Necrosis Factor (TNF) Blockers

THOUSAND OAKS, Calif. and COLLEGEVILLE, Pa., Aug. 4 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN ) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE ), issued a statement in response to the Food and Drug Administration (FDA) announcement regarding the results of a safety rev...

CCHRINT Announces FDA Reported Psychiatric Drug Side Effects Search Engine

Citizens Commission on Human Rights International Announces FDA Reported Psychiatric Drug Side Effects Search Engine: Decrypted FDA reports reveal 4,260 suicides, 2,452 additional deaths, 195 homicides from 2004-2006 alone Los Angeles, CA (PRWEB) -- For the first time t...

Veracord Delivers FDA Expertise with SyberWorks Latest Learning Management Solution

Veracord™, ( www.veracord.com ), a privately held consulting company, announced today its marketing partnership with SyberWorks Incorporated, a leader in custom Learning Management System solutions. Veracord's comprehensive validation and compliance expertise extends the SyberWorks web-base...

Watson Pharmaceuticals Receives FDA Approval for Generic Toprol XL(R) 25 MG and 50 MG

MORRISTOWN, N.J., Aug. 3 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI ), a leading specialty pharmaceutical company, today announced that its subsidiary, Watson Laboratories, Inc., has received approval today from the United States Food and Drug Administration...

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FDA in Medical Technology

Video: FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia

TITUSVILLE, N.J., Aug. 3 /PRNewswire/ -- The U.S. Food and Drug Administration approved INVEGA(R) SUSTENNA(TM) (paliperidone palmitate) extended-release injectable suspension for the acute and maintenance treatment of schizophrenia in adults on Friday, July 31, 2009. It is the first ...

Acura and King Receive FDA Complete Response Letter Regarding Acurox(R)

PALATINE, Ill. and BRISTOL, Tenn., July 2 /PRNewswire-FirstCall/ -- Acura Pharmaceuticals, Inc. (Nasdaq: ACUR ) and King Pharmaceuticals, Inc. (NYSE: KG ) announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding the New Drug Application (...

Takeda Receives FDA Complete Response Letter for Alogliptin, an Investigational Treatment for Type 2 Diabetes

DEERFIELD, Ill., June 26, and OSAKA, Japan, June 27, 2009 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda Global Research & Development Center, Inc., a wholly owned United States (U.S.) subsidiary received on June 26 (U.S. time) a complete response ...

Cytel Signs Cooperative Research And Development Agreement With FDA Center for Devices and Radiological Health (CDRH)

Adaptive trials leader and CDRH regulators join to create Bayesian trial design and analysis software standard CAMBRIDGE, Mass., June 22 /PRNewswire/ -- Cytel Inc., a leading provider of biostatistical software and clinical trial design services, today announced the signing of a Cooperative...

VIA Pharmaceuticals Meets With FDA to Discuss Next Steps For VIA-2291 and Phase 3 Outcome Trial in Cardiovascular Disease

Safety and Biologic Activity Data Reviewed in End of Phase 2a Meeting SAN FRANCISCO, June 11 /PRNewswire-FirstCall/ -- VIA Pharmaceuticals, Inc. (Nasdaq: VIAP ), a biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic disease, annou...

PARI Pharma Reports Successful Phase Ib Clinical Results for Inhaled Liposomal Cyclosporine A and Gains FDA Orphan Drug Designation for the Prevention and Treatment of Bronchiolitis Obliterans

MONTEREY, Calif., June 2 /PRNewswire/ -- This month's Journal of Aerosol Medicine and Pulmonary Drug Delivery features positive Phase Ib clinical trial results for PARI Pharma's L-CsA, inhaled liposomal cyclosporine A. In May, PARI Pharma received Orphan Drug Designation from the Food and Drug Ad...

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FDA in Medical Products

RESTOREADVANCED Neurostimulator

Description:... RESTOREADVANCED is a rechargeable neurostimulator equipped with a battery that can be recharged. This battery has a 9-year fda approved battery life. It is the longest lasting battery on the market. This is helpful to people who require stronger stimulation to relieve their pa...
Company:Medtronic Neurological and Spinal

AlloDerm

Description:...ration's (FDA) guidelines. Since AlloDerm is regarded as minimally processed and not significantly changed in structure from the natural material, the fda has classified it as banked human tissue....
Company:LifeCell Corp.

Pro Osteon 200R Bone Graft Substitute

Description:...arbonate. Originally cleared for use in oral maxillofacial procedures as a very slow resorbing material, the faster-resorbing Pro Osteon 200R has been fda indicated as a bone graft substitute that resorbs and is replaced with bone during the healing process. Its interconnected porosity, chemical composit...
Company:Biomet, Inc.

Monitect Multiple Drug Screen Cassette Test

Description:... Simply collect sample, pipette into testing wells and read results. Monitect is a fda 510K cleared multiple drug screen cassette that can simultaneously test for both drugs and adulterants. It can test from one (1) to five (5) drugs and...
Company:Branan Medical Corp.

Prentice Hall Nurse's Drug Guide 2006

Description:... and accurate drug administration information in a quickly accessible format. The fully revised 2006 edition includes the latest drugs approved by the fda with key nursing implications are highlighted throughout. This include Prototype Drugs for easier learning....
Company:Skyscape, Inc.

Physicians' Cancer Chemotherapy Drug Manual 2005

Description:...o use catalog of over 100 drugs both on and off label commonly used in cancer treatment. This new edition includes new agents (recently or about to be fda approved)....
Company:Skyscape, Inc.
FDA in Medical Definition

Anthrax Vaccine Immunization Program

...ton administration . Thereafter it ran into a few fda and judicial obstacles (mainly concerning the met...nsent in April 2005. On December 15, 2005 , the fda re-issued a Final Rule & Order [8] on the l...arefully considering comments from the public, the fda again determined that the vaccine is licensed for ...

Artecoll

...tecoll has been used in Europe for many years. It was approved by the U.S. fda in December, 2006, to treat nasolabial folds with the added condition that... External links Artecoll before and after pictures Landmark U.S. fda Clinical Trial Results for First Permanent Injectable Wrinkle Filler Publis...

Extracorporeal shockwave therapy

... musculo-skeletal conditions. Presently it is only fda approved for treatment of plantar heel spurs, plan...tures and shoulder calcification. There is also an fda study to treat recalcitrant diabetic wounds. The... promote healing. For treatment of heel pain the fda study criteria is quite specific. A person has had...

Personalized medicine

...hat personalized medicine is going to make a profound impact on society and they are guiding this process. Dr Andrew VonEschenbach, Director of the fda recently gave a briefing to the Personalized Medicine Coalition at the National Press Club. He and the organization are truly committed to bring new ...

Sexual orientation and medicine

...esting a genetic component to sexual orientation. [3] 1995 Saquinavir , the first protease inhibitor is approved for public use by the fda . HAART radically changes the prognosis of HIV/AIDS . 1996 The US Department of Defense includes homosexuality in a list of "mental disord...

Surrogate markers

... to test the effectiveness of a treatment for a fatal disease without having to wait for a statistically significant number of deaths to occur. the fda will often accept evidence from clinical trials that show a benefit to surrogate markers instead of to end points. A commonly used example is ch...
FDA in Medical Dictionary

Tolmetin

...Drug information on prescription and over the counter medications includes drug interactions, uses, side effects, and drug dosing. Accurate, fda approved Tolmetin information for healthcare professionals and patients - brought ... Tolmetin sodium is contraindicated for the treatment of ...

Sutures

...ppliers. Find a reliable & professional sutures manufacturer or supplier. ... Search : sutures 1,674 ... Surgical Sutures (Silk) with CE and fda ... after birth, prominent lens Y sutures , and a round, ... placing vertical mattress sutures to evert the offend ... Horizontal mattress s...

Ritalin

... used to treat attention deficit disorder (ADD) and narcolepsy. ... Do not use Ritalin if you have used an MAO inhibitor such as ... Accurate, fda approved Ritalin information for healthcare professionals and patients ... Ritalin in the SR tablets is more slowly but as extensively ... Des...

Purulent

.... evidence of pneumonia in association with the production of purulent sputum ... All my custom Homeopathic remedies are SAFE, EFFECTIVE AND fda APPROVED. ... Wet- Purulent Eczema Formula 30C webcode vit054. RESPIRATORY FORMULAS ... ...

Phenylketonuria

.... MedlinePlus Encyclopedia: Phenylketonuria ... Phenylketonuria ... fda Approves Kuvan for Treatment of Phenylketonuria (PKU)(Food and Drug Admin...ketonuria ) is an inherited disorder that can cause mental retardation. ... fda Approves Kuvan for Treatment of Phenylketonuria (PKU), December 13, 2007....

Patent foramen ovale

...PFO) - Signs and symptoms - Diagnosis methods - Treatment options ... Patent Foramen Ovale . Atrial Septal Defect. Ventricular Septal Defect. fda Disclaimer ... A patent foramen ovale , or PFO, results from an incomplete closure of ... Patent foramen ovale — Comprehensiv...
FDA in Biological News

Hebrew University professor's work leads to FDA approval for product

Jerusalem, March 25, 2009 A material developed at the Hebrew University of Jerusalem that is designed to prevent adhesions (scar tissue) following surgery has led to approval by the U.S. Food and Drug Administration (FDA) of a product for use in pediatric cardiac surgery patients. The product...

Director of Berman Institute comments on FDA Approval of first human embryonic stem cell trial

"The report today that the FDA has approved the first human clinical trial of an embryonic stem cell-based intervention raises important ethical considerations, but not only, or even primarily, because what is at issue is an embryonic stem cell-based intervention. Although deep-seated disagreemen...

Expert urges FDA to take action to reduce BPA exposure

COLUMBIA, Mo. In the current issue of the Journal of the American Medical Association ( JAMA ), researchers report a significant relationship between urine concentrations of the environmental estrogen bisphenol A (BPA) and cardiovascular disease, type 2 diabetes and liver-enzyme abnormalities. ...

Ikaria(R) Receives FDA Orphan Drug Designation for Inhaled Carbon Monoxide for Delayed Graft Function in Solid Organ Transplants

CLINTON, N.J., July 28 /PRNewswire/ -- Ikaria Holdings, Inc., a fully integrated critical care biotherapeutics company, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for inhaled carbon monoxide for use in the reduction of the incidence and...

Ikaria(R) Receives FDA Orphan Drug Designation for Inhaled Carbon Monoxide for Delayed Graft Function in Solid Organ Transplants

CLINTON, N.J., July 28 /PRNewswire/ -- Ikaria Holdings, Inc., a fully integrated critical care biotherapeutics company, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for inhaled carbon monoxide for use in the reduction of the incidence and...

UNC study questions FDA genetic-screening guidelines for cancer drug

CHAPEL HILL Not everyone needs a genetic test before taking the cancer drug irinotecan, and the U.S. Food and Drug Administration should modify its prescription guidelines to say so, according to researchers at the University of North Carolina at Chapel Hill. Irinotecan, also known by its bran...

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FDA in Biological Technology

Cell Therapeutics Second Quarter Net Loss Decreases 54%; Pixantrone NDA Submitted to the FDA for Approval

SEATTLE, Aug. 6 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) today reported recent achievements and financial results for the second quarter and six months ended June 30, 2009. "The second quarter of 2009 was a transforming quarter for the Co...

Exciton Technologies receives FDA approval to market exSALT(TM)

EDMONTON, Aug. 5 /PRNewswire/ - Exciton Technologies Inc. today announced that the Company has received approval from the United States Food and Drug Administration (FDA) to market exSALT(TM) SD7 Wound Dressing, a product incorporating Exciton's patented platform coating technology utilizing silve...

DOR BioPharma Receives FDA Orphan Drug Designation for orBec(R) for the Treatment of Chronic Gastrointestinal GVHD

PRINCETON, N.J., Aug. 4 /PRNewswire-FirstCall/ -- DOR BioPharma, Inc., (OTC Bulletin Board: DORB) (DOR or the Company), a late-stage biopharmaceutical company, announced today that the Office of Orphan Products Development of the United States Food and Drug Administration (FDA) has granted Or...

AEterna Zentaris Partner, Keryx, Announces Agreement with FDA on a Special Protocol Assessment for Phase 3 Trial with Perifosine (KRX-0401) for the Treatment of Multiple Myeloma

QUEBEC CITY, Aug. 3 /PRNewswire-FirstCall/ - AEterna Zentaris Inc. (NASDAQ: AEZS , TSX: AEZ), ("the Company") a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX ), its partner and licensee for perifosi...

Advanced Life Sciences Receives Complete Response Letter From FDA for Restanza(TM) (Cethromycin) in Community Acquired Pneumonia

CHICAGO, July 31 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS) announced that it received a complete response letter today from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Restanza(TM) (cethrom...

Anadys Pharmaceuticals Receives FDA Clearance of Phase II Protocol to Study ANA598 in Combination With Interferon-Alpha and Ribavirin in HCV Patients

SAN DIEGO, July 30 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS ) today announced finalization of the protocol for the Company's Phase II trial of ANA598 in combination with pegylated interferon-alpha and ribavirin in hepatitis C patients. Allowance o...

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FDA in Biological Products

Human Serum Off The Clot from Lifeblood Medical, Inc.

Description:... Human Serum fda Licensed US Donor Centers Sterile / Non-sterile: Sterile Filtered to 0.2 micron Information: Extensive Viral Testing ...
Company:Lifeblood Medical, Inc.

Normal Human Serum from CHEMICON

Description:... Normal human serum collected off the clot from healthy normal humans. Each donor unit is negative for anti-HIV 1&2, HIV-Ag, HCV, and HBsAg by fda required tests...
Company:CHEMICON

Infinite F200 from Tecan

Description:...tocols to suit their own application. Furthermore, optional Magellan software packages provide full data reduction capability and are designed to meet fda regulation 21 CFR Part 11. Infinite F200 product highlights include: Modular concept allowing for later upgrades. Injector system for triggeri...
Company:Tecan

Luminex 100 IS System from Luminex Corporation

Description:...cludes the Luminex 100, the XY Platform, and the SD. Also, it has a DMF file at the FDA, and partner kits that have received 510(k) clearance from the fda can be used on the Luminex 100 IS system. It utilizes xMAP technology which enables you to simultaneously assay up to 100 analytes in a single well of...
Company:Luminex Corporation

Infinite M200 from Tecan

Description:...tocols to suit their own application. Furthermore, optional Magellan software packages provide full data reduction capability and are designed to meet fda regulation 21 CFR Part 11. Infinite M200 product highlights include: Modular concept allowing for later upgrades. Injector system for triggeri...
Company:Tecan

Freedom EVOware from Tecan

Description:...ng arm up to multi-microplate scheduled runs on a fully configured Freedom EVO 200. Freedom EVOware is also ideal for laboratories working under the fda 21 CFR part 11 regulation needing multilevel user management, full audit trail, electronic records and electronic signatures. Freedom EVOware highl...
Company:Tecan
FDA in Biological Definition

Biotechnology

...i , is used to produce insulin and other medicine, in human form. (About 5% of diabetics are allergic to animal insulins available before) 1992 fda approves of the first GM food from Calgene : "Flavr Savr" tomato 1999 Biotechnology program started at North Montgomery County Technical Career C...

Colchicine

...hanges, it also inhibits neutrophil motility and activity, leading to a net anti-inflammatory effect. Colchicine as medicine Colchicine is fda -approved for the treatment of gout and also for familial Mediterranean fever , amyloidosis , and scleroderma . Side-effects include gastro-intes...

Monoclonal antibody

...bodies for cancer treatment 2.2 Chimeric and humanized antibodies 2.3 fda approved monoclonal antibodies Production If a foreign sub... genetically engineered mice that produce more human-like antibodies. fda approved monoclonal antibodies This is a list adapted from information i...

Selective serotonin reuptake inhibitor

... supplementing with tryptophan will. In 1989, the fda made tryptophan available by prescription only,...atric cases of depression is now recognized by the fda as warranting a cautionary statement to the parent... MEDLINEplus drug information database The fda Ban of L-Tryptophan References Tamam, L...
FDA in Biological Dictionary

Transgenic animals

...ll other transgenic animals is subject to the NIH Guidelines ... No. Most transgenic animals under development are regulated by one or more fda Centers. ... To date, no transgenic animals have been approved for use as human food. ... We suggest that you establish a PCR assay to rapidl...

Tetracycline

... Includes tetracycline side effects, interactions and indications. ... Tetracycline can make birth control pills less effective. ... Accurate, fda approved Tetracycline information for healthcare professionals and patients - brought to you by Drugs.com. ... Tetracycline is a yellow, odorless,...

Synapse

...ailable again soon! Checkout The Complete Synapse Collections! ... with Cast and Crew. More Synapse Films titles now available on ... The newly fda approved NeuRx Diaphragm Pacing System™ introduces groundbreaking ... ©2008 Synapse Biomedical Inc. • Contact Us • Login ... synapse ( ) n. The...

Ovules

...elopment. 2.1 Integuments, micropyle and chalaza ... Depending on the plant, flowers may have one or multiple ovules per ovary. ... Accurate, fda approved Cleocin Vaginal Ovules information for healthcare professionals and patients - brought to you by Drugs.com. Learn about the prescription...

Operculum

...ls ... What is the function of the operculum on a fish? ... ZR- Operculum is dedicated to identifying the priorities of women and their ... not fda approved. Not for sale in the U.S. ©2009 ZR- Operculum / Privacy Policy ... The result is a concentric operculum with the oldest part in the cen...

Norepinephrine

...ephrine , bisulfites (contains metabisulfite), or any ... Norepinephrine is effective at increasing arterial blood pressure through ... Accurate, fda approved Norepinephrine information for healthcare professionals and patients - brought ... Norepinephrine is supplied in sterile aqueous ... P...
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